MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHOICE PT; WIRE, GUIDE, CATHETER

Model Number	2045
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coating was peeling.A 182 cm choice guidewire was selected for use.During unpacking of the device, it was noted that the wire coating was peeling.The procedure was completed with another of the same device.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic inspection was performed.The distal tip of the device was bent.Peeling of the hydrophobic coating was noted on the distal tip of the guidewire.
Event or Problem Description
It was reported that the coating was peeling.A 182 cm choice guidewire was selected for use.During unpacking of the device, it was noted that the wire coating was peeling.The procedure was completed with another of the same device.

• Brand Name: CHOICE PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19578553
• Report Number: 2124215-2024-37917
• Device Sequence Number: 20935047
• Product Code: DQX
• UDI-Device Identifier: 08714729252528
• UDI-Public: 08714729252528
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2025
• Device Model Number: 2045
• Device Catalogue Number: 2045
• Device Lot Number: 0033093738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown